Wednesday, May 30, 2018

Guest Post: Practicing what I preach about generic drugs

- Kathleen "Cook" Uhl, MD

In 2015, I was treated for stage 3 colorectal cancer. All of my cancer medications – from the chemotherapy right down to the anti-nausea medications – were generics.

Why did I take only generic medicines? Through my work at the U.S. Food and Drug Administration (FDA), I know that FDA-approved generic drugs meet the Agency’s high standards for safety, efficacy, and quality. So when my doctors at Walter Reed National Military Medical Center prescribed me generic cancer medications, I was confident that the generic prescriptions were as high-quality as brand-name medications, and could be substituted for the brand-name drug with no difference in safety or efficacy.

The generic drug approval process is supported by solid scientific research and review. Generic drug manufacturers must demonstrate their product is pharmaceutically equivalent and bioequivalent to the brand-name product before it can be approved. They also must demonstrate that the generic drug can be reliably and consistently manufactured in a way that maintains this equivalence and quality.

Pharmaceutical equivalence means that the generic has the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. Formulations may differ in inactive ingredients, provided that the generic drug manufacturer shows the inactive ingredients are safe and do not change the way the active ingredients are delivered to the body. Generic drugs may also have differences in characteristics such as size, shape, or color.

FDA standards of bioequivalence often require companies to conduct in vivo bioequivalence studies. Typically, volunteers take the brand-name and generic drug products to demonstrate that there is no significant difference between the rate and extent of absorption of the active ingredient. A bioequivalent drug will behave the same way in patients as its brand-name counterpart. FDA scientists compare data from these studies to ensure that a generic drug can be substituted for its brand-name counterpart and will behave the same way in patients.

Makers of generic drugs also submit data to FDA to show how the processes of combining the active and inactive ingredients to make the generic drug meet the same standards as the brand-name drug. It is only when a generic drug manufacturer has demonstrated that it can reliably make a high-quality, pharmaceutically equivalent and bioequivalent product that it can be made available to patients.

I am a cancer survivor. I am alive today because of the love and support of my family, friends, and co-workers. I am alive because of the incredible doctors and medical staff at Walter Reed. I am also alive because of generic drugs. Generic drugs saved my life.

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Dr. Kathleen "Cook" Uhl is Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. Her editorial "How the FDA Ensures High-Quality Generic Drugs" appeared in the June 1 issue of AFP.

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